Actively Recruiting

Age: 0 - 18Years
All Genders
ID06519175

Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities

Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-26

1000

Participants Needed

7

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

Istituto Ortopedico Rizzoli

Lead Sponsor

O

Ospedale Pediatrico Bambino Gesù

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on children and adolescents with skeletal defects and deformities of the lower limbs, which can be congenital or acquired. These conditions may cause deformities, short stature, and disability, affecting both physical and mental health as well as family life. The study aims to support clinical practice through a comprehensive evaluation of these deformities and gather data on treatment approaches used in leading centers. The study observes patients receiving various management approaches, including physiotherapy and prostheses as conservative treatments, single or multi-stage surgeries with different techniques to correct deformities, and amputations when necessary to improve walking function using prostheses. Treatments are personalized depending on each patient's needs and surgical preferences. Participants will undergo clinical examinations and assessments of lower limb function and mental health at the start of the study and after one year. Researchers will collect data using the Pediatric Outcomes Data Collection Instrument and monitor changes over time. The study is observational and prospective, lasting at least one year with regular follow-up evaluations to understand the outcomes of different treatment methods.

CONDITIONS

Brief Title

Study of Infantile Lower Limb Malformations and Deformities

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Under 18 years of age at the time of initial orthopedic evaluation
  • Diagnosed with congenital or acquired musculoskeletal deformity affecting one or both lower limbs
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study by the patient or parent/legal guardian
  • Mild limb differences not causing functional limitations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Observational Monitoring

Duration - 1 year

Participants undergo clinical examinations and assessments to monitor lower limb malformations and deformities over time.

Assessments at baseline and after 1 year

Trial Site Locations

Total: 7 locations

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

2

Istituto Giannina Gaslini

Genova, Italy

Not Yet Recruiting

3

Galeazzi Orthopedic Institute

Milan, Italy

Not Yet Recruiting

4

Policlinico San Matteo

Pavia, Italy

Not Yet Recruiting

5

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Not Yet Recruiting

6

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Not Yet Recruiting

7

Istituto Clinico Humanitas

Rozzano, Italy

Not Yet Recruiting

Loading map...

Research Team

G

Giovanni Trisolino, MD

A

Alessandro Depaoli, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

What matters to children with lower limb deformities: an international qualitative study guiding the development of a new patient-reported outcome measure.

Harpreet Chhina, Anne F Klassen, Jacek A Kopec...

https://pubmed.ncbi.nlm.nih.gov/33792793

Reliability of the Modified Clavien-Dindo-Sink Complication Classification System in Pediatric Orthopaedic Surgery.

Emily R Dodwell, Rubini Pathy, Roger F Widmann...

https://pubmed.ncbi.nlm.nih.gov/30882054